Trial Title:
A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.
NCT ID:
NCT06542250
Condition:
B-cell Malignancies
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
CD20
CD8
T cell engager
TCR
AZD5492
Relapsed, Refractory
B-cell malignancies
CLL, Chronic lymphocytic leukemia
SLL, Small lymphocytic lymphoma
MCL, Mantle cell lymphoma
LBCL, Large B-cell lymphoma
FL, Follicular lymphoma
TITANium
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
The study consists of individual modules each evaluating the safety, tolerability, PK,
immunogenicity, pharmacodynamics, and preliminary efficacy of AZD5492 as monotherapy or
in combination with other anticancer treatments in participants with R/R B-cell
malignancies.
- Module 1: AZD9592 Monotherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AZD5492
Description:
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered
subcutaneously
Arm group label:
Module 1: AZD5492 Monotherapy
Summary:
This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody
targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed
or Refractory B-Cell Malignancies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥18 years of age;
- Histologically documented CD20+ mature B-cell neoplasm
- Large B-cell lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Relapsed, progressive and/or refractory disease following at least 2 prior lines of
therapy;
- ECOG performance status of ≤ 2.
The above is a summary, other inclusion criteria details may apply.
Exclusion Criteria:
- Active CNS involvement in lymphoma or CNS pathology;
- Diagnosis of post-transplant lymphoproliferative disease, Richter's transformation,
Burkitt's lymphoma, or Burkitt-like lymphoma;
- Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell
therapy within 90 days of start of therapy;
- History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS;
- Active and uncontrolled infections;
- Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions
The above is a summary, other exclusion criteria details may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Charlotte
Zip:
28203
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Concord
Zip:
28025
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Calgary
Zip:
T2N 4N2
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H3T 1R2
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
København Ø
Zip:
2100
Country:
Denmark
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
München
Zip:
81675
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ulm
Zip:
89081
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
L'Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Not yet recruiting
Start date:
September 18, 2024
Completion date:
February 16, 2028
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06542250
